Press Release

Thursday, 22 October 2015

Start of the ARISE clinical trial - First patient included at Hanover Medical School / EACTS 2015 Techno College Presentation


The ARISE clinical study has started in Hannover with the inclusion of the first patient, a 24-year-old man with severe aortic stenosis, due to a degenerated bioprosthesis,  and markedly reduced left ventricular function.  The implantation of a 26 mm decellularized aortic homograft was successfully performed on September 24th by a team of Hannover Medical School (MHH) surgeons led by Prof. Axel Haverich, coordinator of the ARISE project. The patient`s postoperative course was uneventful and left ventricular function recovered quickly due to the large effective orifice area of the transplanted valve.

Decellularized "homografts" are human donor heart valves, which have been stripped completely of all cells, leaving only a collagen matrix structure. The graft was kindly provided by the European Homograft Bank (EHB), Clinique Saint-Jean, Brussels, Dr. R. Jashari. Decellularization was performed by corlife oHG, Hannover, Germany at the spin-off’s specially equipped laboratory, following the market approval of ARISE AV, which was issued by the Paul-Ehrlich Institute in Germany in July 2015.

In addition to the MHH, the ARISE consortium includes five other leading European heart centers. The study will enroll a total of 120 patients in Hannover, Barcelona, Padua, London, Leuven and Leiden.

Prof. Jose L. Pomar and Dr. Igor Tudorache presented the ARISE project during the Techno College of the 2015 European Association for Cardio-Thoracic Surgery (EACTS) in Amsterdam. The technique for decellularization was explained and a 3D-video of an extended aortic root replacement using a long decellularized homograft was shown and extremely well received by conference attendees. Several additional clinics expressed their interest in participating in the ARISE study, a point which was later discussed at the ARISE Steering Committee Meeting during the EACTS conference.



Figure 1: Decellularized aortic valve (ARISE AV) after implantation exhibiting a large effective orifice area (EOA) of >4cm2 and competent pliable cusps.